MAUDE Adverse Event Report: AESCULAP AG & CO. KG HALSTED-MOSQUITO FCPSDELSTR1X2125MM; HAEMOSTATIC FORCEPS

Model Number BH120R

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: after finishing the surgery, the customer found tip of the jaw is missing.And that fragment has not been found yet.

Manufacturer Narrative

U.S.Reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: the investigation determined the issue had been caused by a manufacturing error, which was not detected in final inspection.However, all responsible persons have been informed about it and it should be avoided in the future.All known complaints with this failure have been produced in 2012.As oem did not receive any more issues since then, it is assumed that one or few batches in 2012 were affected.

• Brand Name: HALSTED-MOSQUITO FCPSDELSTR1X2125MM
• Type of Device: HAEMOSTATIC FORCEPS
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG & CO. KG; p.o. box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4047730
• MDR Text Key: 4811387
• Report Number: 2916714-2014-00647
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BH120R
• Device Catalogue Number: BH120R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other